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TheStreet Open House

Biotech Calendar: 2011 FDA Drug Approvals

Updated with new information regarding Pacira Pharmaceuticals and clarified the regulatory status of Cell Therapeutics.

BOSTON ( TheStreet) -- The 2011 FDA drug approval calendar has been updated.

For easier reference, this regulatory calendar is organized in chronological order based on the drug approval decision date. Information on pending FDA advisory panels is also included.

Optimer Pharmaceuticals (OPTR)
Drug/indication: Dificid for Clostridium difficile infection
FDA approval decision date: May 30, 2011

GlaxoSmithKline (GSK) and Valeant Pharmaceuticals (VRX)
Drug/indication: Potiga for partial seizures due to epilepsy
FDA approval decision date: June 14, 2011
Glaxo and Valeant submitted on April 15 a response to the FDA's complete response letter for Potiga which was delivered on Nov 30, 2010.

Bristol-Myers Squibb (BMY)
Drug/indication: belatacept for kidney transplant rejection
FDA approval decision date: June 15, 2011
FDA initially rejected belatacept in May 2010.

Pfizer (PFE) and Acura Pharmaceuticals (ACUR)
Drug/indication: Acurox, an abuse-resistant, immediate-release opioid. Approval decision date: June 17, 2011

Regeneron Pharmaceuticals (REGN)
Drug/indication: VEGF Trap-Eye for wet age-related macular degeneration
FDA advisory meeting: June 17, 2011
Approval decision date: Aug. 20, 2011

Salix Pharmaceuticals (SLXP)
Drug/indication: Xifaxan for irritable bowel syndrome (IBS)
FDA meeting: June 20, 2011
Xiafaxan is already approved for travelers' diarrhea and hepatic encephalopathy but FDA rejected the drug for IBS in March, requesting additional retreatment data. Salix is expected to update investors on the timeline for Xifaxan's IBS resubmission following the June 20 meeting with FDA.

Fibrocell Science (FCSC.OB)
Drug/indication: laViv for treatment for nasolabial folds and wrinkles
Approval decision date: June 22, 2011

Pain Therapeutics (PTIE), Durect Corp. (DRRX) and Pfizer (PFE)
Drug/indication:: Remoxy, an abuse-resistant opioid for moderate to severe pain.
Approval decision date: June 23, 2011

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